Category Archives: Erudition & Culture

Liverpool Researchers Awarded £6 Million to Develop Long-Acting Treatments for Neglected Diseases in Developing Countries

A University of Liverpool project has received a significant boost in its fight against major diseases. Unitaid, a global health organization, awarded over £6 million to the initiative, titled LONGEVITY. This project focuses on developing long-acting treatments for tuberculosis, malaria, and hepatitis C, specifically targeting low- and middle-income countries (LMICs).

Cadrenal Therapeutics’ Tecarfarin Scores Orphan Drug Designation for Preventing Blood Clots in Heart Assist Device Patients

Cadrenal Therapeutics’ Tecarfarin Scores Orphan Drug Designation for Preventing Blood Clots in Heart Assist Device Patients
Cadrenal Therapeutics, a biopharmaceutical company developing innovative blood thinners, recently announced a significant development for their late-stage drug Tecarfarin. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Tecarfarin for preventing blood clots in patients with implanted mechanical heart assist devices.

New Combination Therapy Shows Promise for Recurrent Ovarian Cancer: Phase 3 Trial Underway

Avutometinib, a drug designed to target a specific pathway in cancer cells, has received orphan drug designation from the FDA for recurrent low-grade serous ovarian cancer. This designation is given to drugs with potential for treating rare diseases.

Researchers are currently evaluating a combination of Avutometinib and Defactinib in a large-scale phase 3 trial called RAMP 301. This trial aims to confirm the effectiveness and safety of the combination for patients with this type of ovarian cancer that has returned after previous treatment.

EMA Strengthens Testing for Cancer-Causing Impurities in Medicines

The European Medicines Agency (EMA) has taken a significant step towards ensuring the safety of medications by updating its recommendations for testing N-nitrosamines, a class of chemicals linked to an increased cancer risk.

N-nitrosamines can form unintentionally during the manufacturing process of some medicines. While their presence is generally very low, even small amounts can be harmful. The updated guidance focuses on improving the detection of these impurities, particularly N-nitrosamine drug substance related impurities (NDSRIs), a recently identified class with a more complex structure.

Quizartinib Approved for First-Line Treatment of FLT3-ITD Positive Acute Myeloid Leukemia in Adults by the MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted marketing authorization for Quizartinib (Vanflyta) as first-line therapy in conjunction with standard chemotherapy for adult patients diagnosed with FLT3-ITD positive acute myeloid leukemia (AML). This decision signifies a significant advancement in the treatment landscape for this specific subgroup of AML patients.

New Treatment Option for Moderately to Severely Active Ulcerative Colitis: Etrasimod Gets UK Approval

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has approved etrasimod (brand name Velsipity) for treating adults (over 16) with moderate to severe ulcerative colitis. This chronic condition causes inflammation and ulcers in the inner lining of the colon and rectum. Symptoms include recurring bloody diarrhea, stomach cramps, fatigue, and weight loss.